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.
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August 2007
- Betamethasone dipropionate, gentamicin sulfate (Diprogenta® cream, Schering-Plough) Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression & to exogenous corticosteroid effects than mature patients because of greater absorption due to a large skin surface area to body weight ratio.
HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain & intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels & absence of response to ACTH stimulation. Manifestations of intracranial hypertension include a bulging fontanelle, headaches & bilateral papilledema.
Diprogenta® cream should be used during pregnancy only if potential benefit justifies potential risk to the foetus.
Diprogenta® cream, should not be used during breast-feeding as the amount of drug secreted in breast milk is unknown. - Carbamazepine (Tegretol®, Novartis) Under "Special warnings & precautions for use", it is stated that toxic epidermal necrolysis (Lyell's syndrome) & Stevens Johnson syndrome have been rarely reported with Tegretol®.Carbamazepine may interact with paroxetine and levetiracetam.
New ADR: Hypogammaglobulinaemia. - Diphtheria toxoid, tetanus toxoid, pertussis antigens, inactivated polio viruses & Hib (Infanrix® IPV+HIB vaccine, GSK) It is warned that in children with progressive neurological disorders like infantile spasms, uncontrolled epilepsy or progressive encephalopathy, it is better to defer pertussis immunization until the condition is corrected or stable. Decision to give pertussis vaccine must be made on an individual basis after careful consideration of risks & benefits.
New ADRs: Local swelling at injection site, diffuse swelling of the injected limb, sometimes involving adjacent joint. Large swelling reactions more likely when children primed with acellular pertussis vaccines vs whole cell vaccine; local swelling & diffuse swelling may be more frequent when booster dose is administered between 4 & 6 years, resolving over an average of 4 days.
Swelling of the entire injected limb has been reported. - Eptifibatide (Intergrilin®, Zuellig) Infusion dose should be reduced to 1mcg/kg/min for cases of moderate-severe renal impairment (CrCl <50 ml/min) due to increased risk of bleeding. Clinical data suggest that the risk of major and minor bleeding due to Integrilin® therapy may be increased in patients weighing less than 70 kg. Cases of pulmonary hemorrhage have also been reported very rarely.
- Galantamine HBr (Reminyl® oral solution, Johnson & Johnson) New ADRs: Hypertension, elevated liver enzymes & hepatitis.
- Lidocaine HCl (Xylocaine® jelly, AstraZeneca) Drugs that reduce clearance of lidocaine e.g. cimetidine or betablocker, may cause potentially toxic plasma concentrations when lidocaine is given in repeated high doses over a long time period.Xylocaine® jelly is probably porphyrinogenic & prescribe only to patients with acute porphyria on strong or urgent indications & precautions for all porphyric patients.
- Lovastatin (Ellanco®, CCM Pharmaceuticals) Dosage: Dosage of lovastatin should be reduced if LDL-cholesterol levels fall below 75mg/dL (1.94mmol/L) or total plasma cholesterol levels falls below 140mg/dL (3.6mmol/L).
Precautions/Warnings:
Hepatic effects: Transaminase tests recommended to be performed before treatment begins & periodically thereafter, particularly in patients who have abnormal liver function tests &/or consume substantial amounts of alcohol & in patients in whom the dose is increased to 40mg/day or more. If serum transaminase levels rise to > 3xs the upper limits of normal, potential risk of continuing lovastatin should be weighed vs anticipated benefits. Drug should be discontinued if elevations are persistent or progressive.
Muscle effects: Transient mild elevation of creatinine kinase (CK) levels, myalgias, myopathy (rare but should be considered in patient with diffuse myalgias, muscle tenderness or weakness &/or marked elevation of CK i.e. 10Xs the upper limit of normal), severe rhabdomyolysis that precipitated ARF. Lovastatin therapy should be discontinued if marked elevation of CK levels occurs or if myopathy is diagnosed or suspected.
Immunosuppressive drugs: The benefits & risk of using lovastatin concomitantly with immunosuppressive or fibrate drugs or lipid-lowering doses of niacin (nicotinic acid) should be carefully considered. Myopathy & rhabdomyolysis have occurred in transplant & non-transplant patients receiving lovastatin or another HMG-CoA reductase inhibitor following the initiation of treatment with itraconazole. Therapy with lovastatin should be temporarily withheld or is continued in any patient with an acute, serious conditions suggestive of a myopathy or having a risk factor predisposing to the development of renal failure secondary to rhabdomyolysis, including severe acute infection, hypotension, major surgery, trauma, severe metabolic, endocrine or electrolyte disorders & uncontrolled seizures.
Homozygous Familial Hypercholesterolemia: In patients with rare homozygous familial hypercholesterolemia, lovastatin was less effective, possibly because these patients have no functional LDL receptors. Lovastatin seems more likely to raise serum transaminase in this group of patients. Hypertriglyceridemia: Lovastatin has only a moderate TG-lowering effect & is not indicated where hypetriglyceridemia is the abnormality of most concern (i.e. hyperlipidemia types I, IV & V).
Pregnancy: Lovastatin is contraindicated in pregnancy. Lovastatin should be given to women of childbearing age only when such patients are highly unlikely to conceive & be discontinued if the patient becomes pregnant while taking it.
Drug Interactions: Myopathy, characterised by myalgia & muscle weakness & associated with increased creatinine phosphokinase concentrations, have been reported esp. in patients taking lovastatin concurrently with itraconazole.
New ADRs: Flatulence, diarrhoea, constipation, nausea, dyspepsia, muscle cramps, myalgia, abdominal pain, fatigue, pruritus, dry mouth, insomnia, sleep disorders, myopathy & rhabdomyolysis (rare). - Metoclopramide HCl (Primperan®, Sanofi-Aventis) Under "Special warnings", it is stated that Primperan® tablets are not to be used in infants & children less than 5 years old.
Under "Interactions", it is stated that selegiline, a MAOI B inhibitor/ dopamine agonist, antagonizes metoclopramide (antiemetic neuroleptic). It is recommended to use an antiemetic that does not give rise to extrapyramidal effects.
No adequate or well-controlled studies in pregnant women, use metoclopramide only if clearly needed. Not recommended during the 1st trimester in pregnant women.
Metoclopramide found in breast milk, hence should not be used during lactation. - Nifedipine (Adalat LA®, Bayer) Under "Special warnings", it is stated that bezoars can occur rarely & may require surgical intervention.Nefazodone is known to inhibit cytochrome P450 3A4 mediated metabolism of other drugs like nifedipine, possibly increasing of nifedipine plasma levels.
New ADRs: Anaphylactoid reaction, anxiety reactions,migraine, par-/dysaesthesia, visual disturbances, palpitations, nosebleed, nasal congestion, GI & abdominal pain, erythema, joint swelling, erectile dysfunction, feeling unwell, unspecific pain. - Oxybutynin chloride (Lyrinel®, Johnson & Johnson) Special warnings:
-Oxybutynin is associated with anticholinergic CNS effects hence patients should be monitored for signs of anticholinergic CNS effects, particularly in the first few months after beginning treatment or increasing the dose. If CNS effects present, reduce dose or discontinue drug.New ADRs: Psychotic disorder, agitation (very rare). - Oxytocin (Syntocinon® injection, Novartis) Under "Interactions", it is stated that as prostaglandins potentiate the effect of oxytocin, it is not recommended that these drugs are used together. If used in sequence, the patient's uterine activity should be carefully monitored.
- Procaterol HCl (Meptin®, Luen Wah Medical) Under "Precautions", it is stated that
-Meptin® should be administered with care in patients who are pregnant or suspected of being pregnant.
-Meptin® should be used only as additional therapy for patients whose symptoms are not adequately controlled & not as a substitute for inhaled corticosteroids & other anti-inflammatory agents. Dosage of inhaled corticosteroids should not be reduced or use of inhaled corticosteroids should not be stopped even if patient is on Meptin unless instructed by the physician.
-During long-term management of bronchial asthma with Meptin, patient may develop acute asthma episodes hence other drugs such as short-acting inhaled beta2 stimulants should be used.
-If use of Meptin® becomes more frequent or therapeutic effect is not observed, the patient's asthma may not be adequately controlled & patient should consult physician for increased dose of inhaled corticosteroids.
Meptin® interacts with xanthine derivatives (e.g. theophylline,aminophylline & diprophylline), corticosteroids & diuretics.
New ADRs: Shock, anaphylactoid reaction, significant decreases in serum potassium levels, increase in blood sugar levels, numbness of limbs, supraventricular extrasystoles, supraventricular tachycardia, ventricular extrasystoles, atrial fibrillation, finger spasm, muscle cramps, muscular spasm, nervousness, increase in AST, ALT, LDH levels & other signs of hepatic dysfunction.
If symptoms of hypersensitivity occur, Meptin® syrup should be discontinued.
Dosage adjustments or other appropriate measures should be considered when prescribing
Meptin® syrup to elderly patients as they may be physiologically more sensitive to it than younger patients. - Salbutamol (Ventolin® solution for iv infusion, GSK) Under "Warnings & precautions", it is stated that
-Lactic acidosis has been reported very rarely in association with high therapeutic doses of iv short-acting beta-agonist therapy, mainly in patients treated for acute asthma exacerbation. Increase in lactate levels may lead to dyspnoea & compensatory hyperventilation, which could be misinterpreted as a sign of asthma treatment failure & lead to inappropriate intensification of treatment hence to monitor these patients for elevated serum lactate & consequent metabolic acidosis.
-Maternal myocardial ischaemia has been reported during or following treatment of premature labour with beta2 agonists. ECG monitoring should be done. If signs of pulmonary oedema or myocardial ischaemia develop, treatment should be discontinued.New ADRs: Lactic acidosis (very rare), palpitations, myocardial ischaemia, pulmonary oedema. - Sodium medronate (Amerscan® medronate II agent for injection, GE Healthcare)Under "Warnings", it is stated that the possibility of hypersensitivity including serious anaphylactic / anaphylactoid reactions should always be considered. Advanced life support facilities should be readily available.New ADR: Life-threatening anaphylaxis (very rare).
- Vinorelbine (Navelbine® Injection, Orient Europharma) Special care should be taken when prescribing for patients with history of ischaemic heart disease.Women of child-bearing potential have to use effective contraception during treatment with Navelbine.
- Warfarin sodium (Marevan®, GSK) New ADRs: Hepatitis, hepatic function abnormal.
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July 2007
- Amoxicillin (Amoxil®, GSK) New ADRs: Mucocutaneous candidiasis, black hairy tongue.
- Anagrelide (Agrylin®, IDS) Elderly patients had twice the incidence of serious adverse events, mainly cardiac.
Anagrelide is contraindicated in patients with moderate or severe hepatic impairment & also in patients with moderate or severe renal impairment (creatinine clearance < 50ml/min). Potential risks & benefits of anagrelide therapy in a patient with mild hepatic impairment should be assessed before treatment is started.
Under "Special warnings", it is stated that
-Cases of cardiomegaly & congestive heart failure have been reported. Anagrelide should be used with caution in patients of any age with known or suspected heart disease, & only if potential benefits of therapy outweigh potential risks. Anagrelide is an inhibitor of cyclic AMP phosphodiesterase (PDE) III & exerts positive inotropic effects. Pre-treatment cardiovascular examination (echocardiography, electrocardiogram) is recommended in patients who should also be monitored during treatment for cardiovascular effects that may require further cardiovascular examination & investigation.
-Anagrelide is not recommended in patients with elevated transaminases (> 5 times the upper limit of normal).
-Concomitant use of anagrelide with other PDE III inhibitors such as milrinone, amrinone, enoximone, olprinone & cilostazol is not recommended.
-Potential risks & benefits of concomitant use of anagrelide with acetylsalicylic acid in patients with a platelet count > 1500 x 10(9)/L &/or a history of haemorrhage should be assessed before starting treatment.
-Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take Agrylin capsules.
Anagrelide interacts with fluvoxamine, omeprazole, theophylline, inotropes like milrinone, enoximone, amrinone, olprinone & cilostazol, hormonal oral contraceptives.
There are no adequate data for the use of anagrelide in pregnant women.
Mothers should discontinue breast-feeding when taking Agrylin due to potential adverse reactions occurring in breast-fed infants.
Under "Undesirable effects", it is stated that gradual dose titration of anagrelide may help diminish adverse effects caused by inhibition of PDE III.
New ADRs: Myocardial infarction, cardiomyopathy, pericardial effusion., pulmonary hypotension, pulmonary infiltrates, hepatic enzymes increased, renal failure, blood creatinine increased, allergic alveolitis. - Aripiprazole (Abilify®, Bristol-Myers Squibb) New adverse effects include: Idiopathic thrombocytopenic purpura, cardiac failure, cardiomyopathy, vertigo, hyperparathyroidism, inguinal hernia, oesophagitis, gastric ulcer haemorrhage, asthenia, cholecystitis, cholelithiasis, hepatitis, hypersensitivity, respiratory tract infections, pneumonia, pyelonephritis, appendicitis, septic shock, fracture, contusion,skin laceration, fall, decreased appetite, musculoskeletal pain, muscle rigidity, cerebral haemorrhage, ischaemic stroke, subarachnoid haemorrhage, pollakiuria, renal failure, erectile dysfunction, benign prostatic hyperplasia, uterine haemorrhage,respiratory failure, circulatory collapse, shock, oropharyngeal spasm, grandmal seizure, jaundice.
- Azathioprine (Imuran®, GSK) New ADRs: Stevens Johnson syndrome & toxic epidermal necrolysis.
- Baclofen (Lioresal®, Novartis) Signs & symptoms of overdosage have been reported with doses above 5 mg daily in patients undergoing chronic haemodialysis as baclofen concentrations in plasma are elevated.Under "Special warnings", it is stated that
-Patients suffering from depressive, manic disorders or Parkinson's disease should be treated with caution as Lioresal may exacerbate these conditions.
-Lowering of the convulsion threshold may occur & seizures have occasionally been reported in connection with the discontinuation of Lioresal or with overdosage.
-Following abrupt withdrawal of Lioresal, dyskinesia & hyperthermia have been reported.
-For the intrathecal formulation of Lioresal, it has been reported that clinical characteristics of withdrawal may resemble autonomic dysreflexia, infection (sepsis), malignant hyperthermia, neuroleptic malignant syndrome, or other conditions associated with a hypermetabolic state or widespread rhabdomyolysis.Baclofen interacts with drugs acting on the CNS, synthetic opiates, alcohol, morphine, levodopa. Careful monitoring of respiratory & cardiovascular functions is essential, esp. in patients with cardiopulmonary disease & respiratory muscle weakness.
Baclofen should not be used during pregnancy unless potential benefit outweighs potential risk to the foetus.New ADRs: Hypothermia, pollakiuria, erectile dysfunction. - Bromocriptine mesylate (Parlodel®, Novartis) As experience with Parlodel SRO in the treatment of children & adolescents is limited, its use in these patients is not recommended.Even though no variation in efficacy or ADR profile in elderly patients taking Parlodel has been observed, dose selection should be cautious, starting at lower dose range.
New ADRs: Libido increase, hypersexuality (Very rare). - Chlorpheniramine (Alleryl®, Apotheca) Alleryl® is contraindicated in patients with known hypersensitivity to chlorpheniramine maleate, in patients intolerant of other anthistamines or sympathomimetics (for e.g. amphetamines, epinephrine, ephedrine, isoproterenol, etc.) & in patients on monoamine oxidase (MAO) inhibitor therapy.
Under "Precautions & warnings", it is stated that:
-Caution should be exercised when using Alleryl® in patients with severe hypertension or cardiovascular disease, bronchitis, bronchiectasis, hepatic disease & thyrotoxicosis.
-Alleryl® may cause drowsiness & dulling of mental alertness hence advise patients to be cautious when driving, operating machinery, or performing other tasks requiring mental alertness. Patients should also abstain from alcohol & other drugs which cause drowsiness.
-Caution should be exercised when prescribing Alleryl® to children & the elderly as they are more prone to neurological anticholinergic effects.
Under "Drug interactions", it is stated that:
-Antihistamines may enhance the sedative effects of CNS depressants including alcohol, barbiturates, hypnotics, opioid analgesics, anxiolytics sedatives & neuroleptics.
-MAOIs including furazolidone, pargyline, procarbazine, may enhance the antimuscarinic effects of antihistamines & antihistamines have additive antimuscarinic action with other antimuscarinic drugs such as atropine & tricyclic antidepressants.
-Concurrent use of ototoxic drugs like aminoglycosides, frusemide, erythromycin, salicylates with Alleryl® may mask the symptoms of ototoxicity such as tinnitus, dizziness or vertigo.
-Concomitant administration of phenytoin sodium & chlorpheniramine has been shown to cause drowsiness, ataxia, diplopia, tinnitus & episodes of occipital headache associated with vomiting due to delayed hepatic metabolism of phenytoin thereby increasing the plasma concentrations.
There is inadequate evidence of safety in human pregnancy hence Alleryl® should only be used during pregnancy when clearly needed & when potential benefits outweigh potential unknown risk to the foetus. Use during the third trimester may result in reaction in neonates.
Alleryl® should not be used during breast feeding due to the risk of adverse effects such as unusual excitement or irritability that results from small amounts of chlorpheniramine excreted in the breast milk.
New ADRs: Hypotension, particularly in geriatric patients at usual doses & palpitations, arrhythmias. - Clobetasol propionate (Univate®, Apex Pharmacy) Univate® is contraindicated in the treatment of peri-anal & genital pruritus & dermatoses in children under one year of age, including dermatitis & nappy eruption.Local side effects may occur, particularly when occlusive dressings are used or when skin folds are involved as these dressings increase the absorption of topical corticosteroids. In infants, the nappy may act as an occlusive dressing.
Severe side effects are likely to happen if application of more than 50g per week is used. - Diclofenac resinate (Cataflam®, Novartis) As a general recommendation, dose of Cataflam® should be individually adjusted & the lowest effective dose given for the shortest possible duration.
Oral drops should be swallowed.
Cataflam® drops should not be given to children under I year of age.
Tablets must not be divided or chewed.Cataflam® is contraindicated in the following:
-Bleeding or perforation of the stomach or intestine.
-Last trimester of pregnancy.
-Severe hepatic, renal & cardiac failure.
-Patients in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by other NSAIDs.Under "Special warnings", it is stated that exfoliative dermatitis, Stevens-Johnson sydrome & toxic epidermal necrolysis have been reported very rarely in association with the use of NSAIDs, including Cataflam. Patients appear to be at highest risk early in the course of therapy with majority of cases occurring within the first month of therapy. Cataflam should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.
Under "Precautions" there are new cautions on use of Cataflam® with systemic NSAIDs; NSAIDs including Cataflam causing asthma exacerbations, Quincke's oedema or urticaria; risk of GI bleeding; fluid retention & edema associated with NSAID therapy and duration of treatment with Cataflam®.
Cataflam® interacts with lithium, digoxin, combinations of antihypertensive agents (e.g. beta-blockers, ACE inhibitors), diuretics, corticosteroids, anti-platelet agents, SSRIs, oral antidiabetic agents & ciclosporin.
Use of diclofenac in pregnant women has not been studied, therefore Cataflam® should not be used during the first two trimesters.
Like other NSAIDs, diclofenac passes into the breast milk in small amounts, therefore Cataflam® should not be administered during breast feeding.
As with other NSAIDs, the use of Cataflam® may impair female fertility & is not recommended in women attempting to conceive. Withdrawal of Cataflam® should be considered in women who have difficulties conceiving or who are undergoing investigation of infertility.Patients experiencing vertigo or somnolence while taking Cataflam® should refrain from driving or using machines.
New ADRs: Angioneurotic oedema (including face oedema), somnolence, cerebrovascular accident, myocardial infarction, gastritis. - Diclofenac (Voltaren Ophtha® eye drops, Novartis) This is not indicated for use in children.
Following instillation of the eye drops, nasolacrimal occlusion or closing the eyes for 3 minutes may reduce systemic absorption, decrease systemic side effects & increase local activity.
Under "Special Warnings & precautions for use", it is stated that
-Caution should be exercised when topical NSAIDs such as diclofenac are used concomitantly with topical steroids.
-Formulation contains benzalkonium chloride as preservative which may cause eye irritation & discolour soft contact lenses.
Under "Interactions", it is stated that
-Concomitant use of topical NSAIDs such as diclofenac & topical steroids in patients with significant pre-existing corneal inflammation may increase the risk of developing corneal complications, therefore caution should be used.
Use of ocular diclofenac is not recommended during breast-feeding unless the expected benefits outweigh the possible risks.
New ADRs: Allergic conditions such as conjunctival hyperaemia, allergic conjunctivitis, eyelid erythema, eye allergy, eyelid oedema, eyelid pruritus, urticaria, rash, eczema, erythema, pruritus, hypersensitivity, cough & rhinitis. - Domperidone (Motilium®, Johnson & Johnson) Motilium® is contraindicated in the co-administration with erythromycin, or other potent CYP3A4 inhibitors which prolong the QTc interval such as fluconazole, voriconazole, clarithromycin, amiodarone & telithromycin.
Main metabolic pathway of domperidone is through CYP3A4. Potent CYP3A4 inhibitors include azole antifungals such as fluconazole, itraconazole, macrolide antibiotics such as erythromycin, HIV protease inhibitors such as amprenavir, atazanavir, calcium antagonists such as diltiazem & others like amiodarone, aprepitant & telithromycin.
New ADRs:very rare cases of angioneurotic oedema & anaphylactic reactions including anaphylactic shock. - Erythromycin (Eryped®, Abbott) Contraindicated in patients taking ergotamine or dihydroergotamine.Post-marketing reports:colchicine toxicity with concomitant use of erythromycin & colchicine; and acute ergot toxicity with ergotamine, dihydroergotamine & erythromycin.
Observational studies in humans have reported cardiovascular malformations after exposure to medicinal products containing erythromycin during early pregnancy.
New ADRs: confusion, hallucinations, seizures, vertigo & tinnitus, pancreatitis, convulsions, interstitial nephritis. - Etoricoxib (Arcoxia®, MSD) The following doses should not be exceeded daily for the following indications: OA - 60 mg, RA - 90 mg,Acute gout -120 mg, Acute pain - 120 mgUnder "Special warnings", it is stated that
-Long term administration of NSAIDs has resulted in renal papillary necrosis & other renal injury.
-Perforations, ulcers or bleeds (PUBs) can occur at any time during use & without warning symptoms though the results of the MEDAL Program demonstrate that risk of GI toxicity in patients treated with Arcoxia 60 mg or 90 mg once daily is significantly less than with diclofenac 150 mg daily.
-Serious skin reactions, some of them fatal, may occur without warning with the use of etoricoxib.New ADR: Shock. - Fulvestrant (Faslodex® solution for injection, AstraZeneca) No dose adjustments are recommended for patients with mild to moderate hepatic impairment but, as fulvestrant exposure may be increased, Faslodex should be used with caution in these patients. No data in patients with severe hepatic impairment (see Contraindications, Special warnings & special precautions for use & Pharmacokinetic properties).
- Isoflurane (Forane® inhalation, Abbott) Isoflurane may trigger malignant hyperthermia with non-specific features like muscle rigidity, tachycardia, tachypnea, cyanosis, arrhythmias & unstable blood pressures.Use of inhaled anaesthesia has been associated rarely with increases in serum potassium levels resulting in cardiac arrhythmias & death in paediatric patients during postoperative period, esp. in those with latent & overt neuromuscular disease, particularly Duchenne muscular dystrophy.
Concomitant use of succinylcholine has been associated with most cases. Patients also experienced significant increases in serum creatine kinase levels & sometimes myoglobinuria. But none of these patients showed signs or symptoms of muscle rigidity or hypermetabolic state. Early & aggressive intervention to treat hyperkalaemia & resistant arrhythmias, subsequent evaluation for latent neuromuscular disease, are recommended. - Lamivudine, Zidovudine (Combivir®, GSK) Under "Special warnings", it is stated that:
-Patients should be cautioned about concomitant use of self-administered medications.
-Clinical features which may indicate development of lactic acidosis include generalised weakness, anorexia & sudden unexplained weight loss, gastrointestinal symptoms (dyspnoea & tachypnoea).
-Signs of hepatotoxicity arising from treatment with Combivir include hepatomegaly & steatosis even in the absence of marked transaminase elevations.
-Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, breast enlargement, elevated serum lipid & blood glucose levels have been observed either separately or together in some patients receiving combination antiretroviral therapy (see Adverse Reactions).
-An inflammatory reaction to asymptomatic or residual opportunistic infections may arise & cause serious clinical conditions, or aggravation of symptoms in HIV-infected patients with severe immune deficiency at the time of initiation of antiretroviral therapy (ART), typically within the first few weeks or months of initiation of ART. Examples are CMV retinitis, generalised &/or focal mycobacterial infections & Pneumocystis jiroveci (P. carinii) pneumonia. Any inflammatory symptoms must be evaluated immediately & treatment initiated when needed.
Under "Interactions", it is stated that
-Atovaquone appears to decrease the rate of metabolism of zidovudine. Extra care should be taken in monitoring patients receiving prolonged atovaquone therapy.
-Clarithromycin tablets reduce the absorption of zidovudine & this can be avoided by administering zidovudine & clarithromycin separately by at least two hours apart.
New ADRs (Lamivudine): Hyperlactataemia, lactic acidosis, redistribution/accumulation of body fat.
New ADRs (Zidovudine): Hyperlactataemia, redistribution/accumulation of body fat. - Lansoprazole (Prevacid®, Luen Wah Medical) Under "Interactions", it is stated that
-Patients monitoring should be done during co-administration of lansoprazole with theophylline.
-Gastric antisecretory effect of Prevacid® may reduce solubility of atazanavir sulfate & hence the blood concentration of atazanavir.Prevacid® is contraindicated in patients who are receiving atazanavir sulfate.
New ADRs: Anaphylactic reactions e.g. generalized rash, facial oedema, dyspnea, shock, toxic epidermal necrolysis (Lyell syndrome), oculomucocutaneous syndrome (Stevens Johnson syndrome), severe hepatic dysfunction with jaundice, hepatitis, agranulocytosis, pancytopenia, haemolytic anaemia, nausea, vomiting, anorexia, abdominal pain, candidiasis, stomatitis, glossitis, taste abnormality, pseudomembranous colitis (due to amoxicillin or clarithromycin used for H.pylori eradication), heartburn & gastroesophageal reflux (observed in clinical studies on H.pylori eradication), interstitial nephritis, acute renal failure, interstitial pneumonia, gynaecomastia, blurred vision, oedema, weakness, malaise, numbness of tongue or lips, numbness of limbs, arthralgia, muscle pain, alopecia, increased TG, +ve urine sugar, protein.
-Discontinue lansoprazole in the following cases:
-Diarrhoea persists.
-Abdominal pain & frequent diarrhoea occurring in H.pylori eradication.
-Abnormalities in renal function test values e.g. increases in BUN, creatinine, etc.
-Fever, coughing, dyspnoea, abnormal lung sound (crepitation),etc. When such symptoms arise, chest X-ray should be performed immediately & patient treated with corticosteroid.
Hepatic impairment leads to an increase in AUC & a reduction in total clearance of lansoprazole hence dose reduction in patients with severe hepatic disease should be considered. - Levofloxacin (Cravit® ophthalmic solution, IDS) New ADRs: Shock, anaphylactoid reactions, rash, blepharitis, eyelid dermatitis, itching, urticaria, irritation, corneal lesion such as keratitis superficial diffuse, conjunctivitis, eye pain.
- Lidocaine (Xylocaine® ointment, AstraZeneca) Drugs that reduce clearance of lidocaine e.g. cimetidine or betablocker, may cause potentially toxic plasma concentrations when lidocaine is given in repeated high doses over a long time period. Such interactions should be of no clinical importance following short term treatment with Xylocaine ointment at recommended doses.
New ADR: Skin irritation may be caused by propylene glycol in ointment. - Metoprolol tartrate (Betaloc®, AstraZeneca) Dose adjustment is normally not needed in patients with liver cirrhosis as metoprolol has a low protein binding (5-10%). However, in cases of serious hepatic impairment (e.g. shunt-operated patients), dose reduction should be considered. Metoprolol is contraindicated in the following patients with:
-Unstable decompensated cardiac heart failure (pulmonary oedema, hypoperfusion or hypotension).
-Continuous or intermittent inotropic therapy acting through beta-receptor agonism.
-Suspected acute myocardial infarction.
-Hypersensitivity to any component of the product or to other beta-blockers.Under "Special warnings & precautions for use", it is stated that
-Intravenous administration of calcium antagonists of the verapamil-type should not be given to patients treated with beta-blockers.
-When treating patients with asthma, concomitant therapy with a beta2-agonist (tablet &/or inhalation) should be administered & dosage increased when metoprolol therapy is started.
-Beta-blocker therapy should not be stopped in patients undergoing surgery.
-Treatment withdrawal should be done over a 14 day period by cutting daily dose in sequential steps, reaching a final dose of 25 mg once daily. Risk for coronary events, including sudden death, may increase during withdrawal of beta-blockade.
Under "Interactions", plasma levels of metoprolol may be raised by antiarrhythmics, antihistamines, histamine-2-receptor antagonists, antidepressants, antipsychotics & COX-2-inhibitors. Plasma levels of metoprolol is lowered by rifampicin & may be raised by alcohol & hydralazine.
-Patients receiving concomitant therapy with monoamine oxidase (MAO) inhibitors should be kept under close surveillance.
-Beta-blockers may enhance the negative dromotropic effect of antiarrhythmic agents.
-Concomitant therapy with prostaglandin synthetase inhibiting drugs may decrease the antihypertensive effect of beta-blockers.
Metoprolol should not be given during pregnancy & lactation unless its use is considered essential.
Patients should know how they react to metoprolol before they drive or use machines because occasionally dizziness or fatigue may occur.
New ADRs (generally mild & reversible): Cold hands & feet, transient deterioration of heart failure symptoms, AV-block I, disturbances of cardiac conduction, hepatitis, arthralgia, concentration impaired, nervousness, anxiety, impotence/sexual dysfunction, amnesia/memory impairment, confusion, hallucinations, taste disturbances, aggravated psoriasis. - Naftidrofuryl hydrogen oxalate (Praxilene®, Merck) Contraindicated in patients with a history of hyperoxaluria.Under "Warnings", it is stated that
-Taking Praxilene without liquid before going to bed may cause local oesophagitis.
-It is recommended to drink large volumes of liquid during the whole treatment period to maintain an adequate level of diuresis & to reduce the formation of calcium oxalate kidney stones.
New ADRs: Nausea, hepatitis. - Nicotinic Acid (Niaspan®, Merck) Combination of nicotinic acid with HMG-CoA reductase inhibitors may increase the risk for myopathy & rhabdomyolysis. New ADRs: Flatulence, eructation.
- Pimecrolimus (Elidel®, Novartis) Use of Elidel® cream in patients under 2 years of age is not recommended until further data becomes available.
- Paricalcitol (Zemplar® injection, Abbott) Chronic renal failure subjects showed a decreased clearance & increased half-life of paricalcitol. New ADRs: Facial & oral oedema.
Multiple doses of ketoconazole administered as 200mg BID for 5 days, have been shown to approximately double the AUC & increase the mean half-life of paricalcitol. - Piroxicam (Feldene®, Pfizer) It is warned that patients taking NSAIDs may be at risk of bleeding, ulceration & perforation any time, with or without warning symptoms, especially the elderly, debilitated, and those with prior history of serious ADRs & other risk factors associated with peptic ulcer disease e.g. alcoholism, smoking & corticosteroid therapy. Under "Special warnings", it is stated that
-There is no consistent evidence that concurrent use of aspirin mitigates the possible increased risk of serious cardiovascular thrombotic events associated with NSAID use.
-Piroxicam can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to increased incidence of cardiovascular events hence use with caution in hypertensive patients. Monitor BP closely during start of therapy & throughout course of therapy.
-Patients should be warned about signs & symptoms of serious GI toxicity especially with concurrent use of aspirin & NSAIDs.
-Serious skin reactions are idiosyncratic & are independent of dose or duration of use.Patients appear to be at highest risk early in the course of therapy like within the first month of therapy in majority of cases. Piroxicam should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. - Risperidone (Risperdal® & Riperdal Consta®, Johnson & Johnson) Care must be taken to avoid inadvertent injection of Risperdal Consta® into a blood vessel. New ADRs: Retinal artery occlusion (in the presence of abnormal arteriovenous anastomosis), QT prolongation.
- Ropinirole (Requip®, GSK) Under "Warnings & precautions", it is stated that compulsive behaviours such as pathological gambling & hypersexuality have been reported in Parkinson's disease patients treated with ropinirole, esp. at high doses & were generally reversible upon dose reduction or treatment discontinuation. In some cases, other factors like a history of compulsive behaviours or concurrent dopaminergic treatment were present.New ADRs: Constipation, oedema peripheral, hypersexuality.
- Salmeterol xinafoate & Fluticasone propionate (Seretide® evohaler, GSK) Under "Special warnings", it is stated that data from a large US study (SMART) comparing the safety of Serevent® (a component of Seretide) or placebo added to usual therapy showed a significant increase in asthma-related deaths in patients receiving Serevent®.
- Trimebutine maleate (Cerekinon®, Pharmaforte) New ADRs: Itching, nausea, vomiting, urticaria, dysuria, anuresis.Dosage may have to be reduced in elderly due to physiological hypofunction.
- Vecuronium bromide (Norcuron® for injection, Organon) Under "Special warnings & precautions for use", it is stated that
-To prevent residual curarization for Norcuron, it is recommended to extubate only after the patient has recovered sufficiently from neuromuscular block.
-Myopathy after long term use of non-depolarizing neuromuscular blocking agents in the ICU with corticosteroid therapy has been reported frequently hence for patients receiving both, period of use of the neuromuscular blocking agent should be limited.
-Because vecuronium is excreted in bile & in urine, Norcuron should be used with caution in patients with clinically significant hepatic &/or biliary diseases &/or renal failure. Prolongation of action has been observed, esp. when high doses of vecuronium were administered in patients with hepatic disease.
-Duration of action of vecuronium may be prolonged due to reduced plasma clearance.
-Neuromuscular blocking effect of Norcuron is increased in operations under hypothermia.
-Norcuron may exhibit prolonged duration & spontaneous recovery in obese patients when administered doses are calculated on actual body weight.
-Patients with burns are known to develop resistance to non-depolarizing agents & dose should be titrated to response.Norcuron may interact with halogenated volatile anaesthetics, suxamethonium, in long-term concomitant use of corticosteroids, lincosamide, calcium channel blocking agents, lithium salts, cimetidine, lidocaine & acute administration of phenytoin or beta-blocking agents, aminoglycoside, polypeptide & acylamino-penicillin antibiotics, quinidine & magnesium salts, other non-depolarizing neuromuscular blocking agents, lidocaine.
In caesarean section, the dose should not exceed 0.1 mg/kg.
No human data on the use of Norcuron during lactation. Only give Norcuron to lactating women when benefits outweigh the risks.
New ADRs: Hypersensitivity anaphylactic reaction, anaphylactoid reaction, anaphylactic shock, anaphylactoid shock, tachycardia, hypotension, circulatory collapse, chock, flushing, bronchospasm, muscular weakness, steroid myopathy, prolonged muscular block, airway complication of anaesthesia, drug ineffective, decreased/increased drug effect/ therapeutic response. - Verapamil HCl (Isoptin®, Isoptin® SR, Abbott) Postmarketing report: paralysis (tetraparesis) associated with the combined use of verapamil & colchicine; combined use is not recommended.Verapamil potentially interacts with the following:
Terazosin, flecainide, imipramine, glyburide, erythromycin, telithromycin, doxorubicin, buspirone, metoprolol, propranolol, digitoxin, sirolimus, tacrolimus, atorvastatin, almotriptan, sulfinpyrazone, St. John's Wort, ritonavir, verapamil, rifampin, colchicine HMG-CoA reductase inhibitors. - Zolpidem (Stilnox®, Sanofi-Aventis) Safety & effectiveness of zolpidem in paediatric patients under 18 years old have not been established. Under "Special warnings & precautions for use", it is stated that
-Symptoms of behaviour disorders are more often observed in elderly subjects.
-Sleep-walking associated with other behaviour such as night-time driving, cooking & eating, using the telephone or engaging in sexual intercourse, with subsequent amnesia, has been reported in patients who had taken zolpidem & were not fully awake.
The use of alcohol & other CNS depressants with zolpidem & use of higher than maximum dose of zolpidem seem to increase the risk of such behaviour.
Discontinuation of zolpidem treatment is strongly recommended in patients who have experienced such behaviour.
-In all cases, insomnia must be systematically assessed & its causes treated before a hypnotic is prescribed.
-Since insomnia may be a symptom of depression, the depression must be treated. If insomnia persists, the patient's condition must be reassessed.
-As there is a risk of suicide in patients with major depression, the lowest amount of zolpidem must be prescribed & supplied to them in order to limit the possibility of intentional overdose.
It is advisable not to use zolpidem at any stage during pregnancy.
New ADRs: Unsteady gait or falls (especially in elderly subjects when dosage recommendations are not followed), diarrhoea, nausea, vomiting, abdominal pain, elevated liver enzymes, angioedema (e.g. Quincke's oedema). - Zolmitriptan (Zomig®, AstraZeneca) New ADRs: Vomiting, hyperaesthesia.
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June 2007
- Bambuterol HCl (Bambec®, AstraZeneca) New ADRs: Nausea, cardiac arrhythmias e.g. atrial fibrillation, supraventricular tachycardia & extrasystoles.
- Cabergoline (Dostinex®, Pfizer) Under "Special wanings", it is stated that a chest x-ray is recommended when new clinical symptoms of respiratory disorders are presented. Dostinex should be discontinued in the case of x-ray signs of pleural effusion/pulmonary fibrosis or in the diagnosis of valvulopathy & this leads to improvement of signs & symptoms.
Pathological gambling, increased libido & hypersexuality (reversible upon reduction of dose or treatment discontinuation) reported.
New ADRs: Alopecia, aggression & psychotic disorder.
- Ceftibuten (Cedax®, Schering-Plough) Under "Interactions", it is stated that cephalosporins, including ceftibuten, can rarely decrease prothrombin activity leading to prolonged prothrombin time (PT), especially in patients previously stabilized on oral anticoagulant therapy. PT or INR should be monitored in patients at risk & treated as required.
New ADRs: Bronchospasm,dyspnoea, rash, urticaria, photosensitivity reaction, pruritus, angioneurotic edema, pseudomembranous colitis, prolongation of PT/INR. - Chlorambucil (Leukeran®, GSK) New ADRs: Leucopenia, neutropenia, thrombocytopenia, pancytopenia & anaemia.
- Clarithromycin (Klacid/Klacid Forte®, Abbott) Post-marketing reports of colchicine toxicity with concomitant use of clarithromycin & colchicine, especially in the elderly, some occurred in patients with renal insufficiency & deaths reported.
Clarithromycin & other macrolides inhibit CYP3A & Pgp (efflux transporter) of which colchicine is a substrate. When clarithromycin & colchicine are administered together, inhibition of Pgp &/or CYP3A by clarithromycin may lead to increased exposure to colchicine resulting in colchicine toxicity. - Ciclosporin (Sandimummn Neoral®, Novartis) Under "Special warnings", it is stated that
-In view of the potential risk of skin malignancy, patients on Sandimmun® Neoral should be warned to avoid excess UV light exposure.
-In elderly patients, renal function should be monitored with particular care.
-Caution should be observed while co-administering lercanidipine with ciclosporin.
-There is only limited experience with the use of Sandimmun® Neoral in children with endogenous uveitis.
New drugs found to affect ciclosporin levels are: oxcarbazepine, bosentan, voriconazole & colchicine.
Methotrexate when given concomitantly with ciclosporin exhibits nephrotoxic synergy.
Following concomitant administration of ciclosporin & lercanidipine, AUC of lercanidipine was increased 3x & AUC of ciclosporin was increased 21%.
Concomitant use of potassium sparing drugs e.g. potassium sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists or potassium containing drugs may lead to significant increases in serum potassium.
- Eletriptan (Relpax®, Pfizer) Caution is needed when co-administering eletriptan with other drugs having serotonergic activity, such as SNRIs & SSRIs due to possible development of serotonin syndrome. Thus, careful observation of the patient is warranted particularly during treatment initiation or dose increase of either eletriptan or SSRIs/SNRIs.
Eletriptan use with potent CYP3A4 inhibitors e.g. ketoconazole, itraconazole, erythromycin, clarithromycin & protease inhibitors (ritonavir, indinavir & nelfinavir) is not recommended. - Glycine (Glycine irrigation® USP, Baxter) ADR terms added are acidosis, electrolyte loss, coma from hyponatremia, secondary hyponatremia due to fluid overload, hyperammonemia with resultant coma &/or encephalopathy, transient blindness.
- Ibandronic Acid (Bonviva®, Roche) Osteonecrosis of the jaw, associated with tooth extraction &/or local infection has been reported in cancer patients receiving mainly iv bisphosphonates & in patients with osteoporosis receiving oral bisphosphonates.
Dental examination with appropriate preventive dentistry should be considered in patients before giving bisphosphonates to those with concomitant risk factors e.g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene. While on treatment, these patients should avoid invasive dental procedures.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Bonviva®. - Indomethacin (Indocin IV®, PL Asia Pacific) Under "Precautions", it is stated that
-Caution should be exercised & prothrombin time monitored closely when Indocin I.v. & anticoagulants are administered concomitantly as bleeding has been reported in patients on concomitant therapy with both during post marketing experience.
-In some patients with compromised renal function, co-administration of an NSAID & an ACE inhibitor or angiotensin II antagonist may further worsen renal function, including possible acute renal failure, which is usually reversible. - Levobupivacaine (Chirocaine®, Abbott) New ADR: Anaphylaxis.
- Lidocaine HCl (Xylocaine®, AstraZeneca) Formulations of lidocaine containing parabens (methyl-/propyl) should be avoided in patients allergic to ester local anaesthetics or their metabolite PABA.
Xylocaine® viscous solution is probably porphyrinogenic & prescribe only to patients with acute porphyria on strong or urgent indications & precautions for all porphyric patients. - Lopinavir, Ritonavir (Kaletra®, Abbott) Kaletra® should not be coadministered with rifampin as large decreases in lopinavir concentrations may significantly decrease the therapeutic effect.
Concomitant use of Kaletra & fluticasone propionate can significantly increase fluticasone propionate plasma concentrations & reduce serum cortisol concentrations. Systemic corticosteroid effects including Cushing's syndrome & adrenal suppression have been reported when ritonavir is co-administered with inhaled or intranasally administered fluticasone propionate.
In a clinical study of dual-boosted protease inhibitor combination therapy in multiple-treatment experienced HIV-positive adults, tipranavir/ritonavir coadministered with lopinavir/ritonavir, resulted in a 47% & 70% reduction in lopinavir AUC & Cmin respectively, hence coadministration of lopinavir/ritonavir & tipranavir with low dose ritonavir is not recommended.
Under "Precautions", it is stated that a literature report has shown that coadministration of ritonavir & digoxin resulted in significantly increased digoxin levels, therefore monitoring of serum digoxin levels is recommended when coadministering these drugs.New ADRs: Myocardial infarct, hepatomegaly, liver fatty deposit, liver tenderness, joint disorder, myasthenia, extrapyramidal syndrome, increased cough, neoplasm, skin striae, impotence. - Midazolam (Dormicum®, Roche) Increased risk for falls & fractures in elderly benzodiazepine users.
- Octreotide (Sandostatin LAR®, Sandostatin Multidose®, Novartis) Under "Special warnings & precautions for use", it is stated that
-Uncommon cases of bradycardia have been reported hence dose adjustments of drugs like beta-blockers, calcium channel blockers, or agents to control fluid & electrolyte balance, may be necessary.
-Octreotide may alter absorption of dietary fats in some patients. Depressed vitamin B12 levels & abnormal Schilling's tests observed in some patients on octreotide hence to monitor vitamin B12 levels in patients on Sandostatin LAR & who have a history of vitamin B12 deficiency.
New ADRs: Anaphylaxis, tachycardia, dyspnoea, cholecystitis, thyroid dysfunction, dyspepsic signs, symptoms & episodes of arrhythmia, ECG changes eg. QT prolongation, axis shifts, early repolarisation, low voltage, R/S transition, early R wave progression, & non-specific ST-T wave changes. - Policresulen, Cinchocaine HCl (Faktu®, Hyphens) Contraindicated in cases of allergy to soya or peanut as they contain soya lecithin liquid.
- Rosuvastatin (Crestor®, AstraZeneca) New ADRs:Arthralgia & memory loss.
- Salmeterol, Fluticasone (Seretide evohaler®, GSK) Under "Special Warnings", it is stated that
-Seretide® should be used with caution in patients with pre-existing cardiovascular disease especially when higher than therapeutic doses are used as Seretide® may increase systolic BP & heart rate.
-Patients should not be started on Seretide® during exacerbation or when asthma is significantly worsening or acutely deteriorating.
-As serious asthma-related adverse events & exacerbations may occur when on Seretide®, patients should continue treatment & seek medical advice if symptoms worsen or remain uncontrolled after starting Seretide®.
-Transient decrease in serum potassium may occur with Seretide® hence caution in patients predisposed to low levels of serum potassium.
Under "Interactions", it is stated that
-Caution needed when potent CYP 3A4 inhibitors are coadministered with fluticasone propionate. Co-administration of orally inhaled fluticasone propionate & ketoconazole has been shown to increase plasma fluticasone propionate exposure & reduce plasma cortisol AUC.
With salmeterol, ADRs reported are anaphylactic reactions like bronchospasm, anaphylactic shock. - Sidenafil (Viagra®, Pfizer) Contraindicated in patients who have experienced vision loss due to non-arteritic anterior ischaemic optic neuropathy (NAION).
- Vitamin B Complex (Becombion®, Merck) Contraindicated in cases of suspected hypersensitivity to thiamine or other ingredients in the composition. Must not be used in newborns, particularly immature preterm infants as Becombion® contains benzyl alcohol. Becombion® is safe for use in nursing mothers who may be at risk of receiving inadequate amounts of vitamins.
Vitamin Bs are excreted into the breast milk but no unphysiological accumulation has been documented.Generally well tolerated but rarely, hypersensitivity reactions e.g. skin reactions, shortness of breath, angio-oedema & conditions of shock may occur, especially following rapid iv injection, thus exercise caution when injecting & inject very slowly. - Warfarin (Marevan®, GSK) Under "Interactions", it is stated that
-Anticoagulant activity may be possibly increased by protease inhibitors.
-St.John's Wort (Hypericum perforatum) may inhibit the anticoagulant activity of Marevan®.
-Additional anticoagulant monitoring may be required at the time of starting, stopping or adjusting the dose of concomitant medications.New ADRs: Leucocytoclastic vasculitis (very rare), bleeding from any site (including but not limited to haemothorax & epistaxis). - Ziprasidone (Zeldox®, Pfizer) In patients with mild to moderate hepatic insufficiency, lower doses should be used. Caution to be exercised in patients with severe hepatic insufficiency due to lack of experience in this group.Under "Special warnings", it is stated that
-There have been rare post-marketing reports of torsade de pointes in patients with multiple confounding risk factors taking ziprasidone though a causal relationship has not been established.
-Neuroleptic Malignant Syndrome (NMS) reported in association with antipsychotic drugs, including ziprasidone. If patient develops signs & symptoms of NMS or presents with unexplained high fever without NMS, all antipsychotic drugs must be discontinued.
-Caution is needed when combining ziprasidone with other centrally acting agents & drugs acting on the dopaminergic & serotonergic systems.
-Elderly patients with dementia-related psychosis are at an increased risk of death compared with placebo when treated with some atypical antipsychotic drugs. Ziprasidone is not approved for such patients.Under "Undesirable effects", it is stated that
-incidence of seizures was rare
-Incidence of extrapyramidal symptoms & akathisia were greater in haloperidol- & risperidone-treated patients relative to ziprasidone.
-Low incidence of body-weight gain & loss reported during clinical trials.
-Transient prolactin increases seen during chronic dosing with ziprasidone.
-New ADRs are: Mania/hypomania, serotonin syndrome (alone or in combination with serotonergic medicinal products), syncope, torsade de pointes, angioedema, galactorrhea, priapism.No studies done in pregnant women. Women of childbearing potential receiving ziprasidone should use an appropriate contraceptive. - Zoledronic Acid (Zometa®, Novartis) Under "Special warnings", it is stated that renal deterioration, progression to renal failure & dialysis have been reported in patients after the initial dose or a single dose of Zometa®.
New ADRs: Atrial fibrillation, somnolence & bronchoconstriction.
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May 2007
Concomitant administration of isosorbide mononitrate (ISMN) & phosphodiesterase type 5 inhibitors can potentiate the vasodilatory effect of ISMN with the potential result of serious side-effects such as syncope or myocardial infarction.
Bone marrow depression (granulocytopenia or agranulocytosis) has been reported with Remeron®. Rarely, agranulocytosis can be fatal which is seen in patients above 65 years. When symptoms like fever, sore throat, stomatitis or other signs of infection occur, treatment should be stopped & blood counts taken.
Careful dosing, regular & close monitoring is needed in patients with epilepsy & organic brain syndrome, hepatic or renal insufficiency, cardiac diseases like conduction disturbances, angina pectoris & recent MI, low blood pressure.
Care should be taken with Remeron® in patients with:
- micturition disturbances like prostate hypertrophy
- acute narrow-angle glaucoma & increased intra-ocular pressure
- diabetes mellitus
- schizophrenia or other psychotic disturbances
When treated with Remeron®, worsening of psychotic symptoms can occur. Depressive phase of manic-depressive psychosis can transform into manic phase. Only a limited number of Remeron® tablets should be given to the patient at the start of treatment to reduce the chance of suicide. Abrupt termination of treatment after long term Remeron® may result in withdrawal symptoms like dizziness, agitation, anxiety, headache & nausea but these symptoms may be due to underlying disease.
Serotonin syndrome occurs very rarely in patients treated with Remeron® alone.
Remeron® should not be used in children & adolescents under 18 years old as suicide-related behaviours & hostility were more frequently observed in clinical trials.
Mirtazapine interacts with HIV protease inhibitors, azole antifungals, erythromycin or nefazodone, carbamazepine & phenytoin, cimetidine, MAO inhibitors (or within 2 weeks after discontinuation of MAO inhibitor therapy) benzodiazepines, sedatives, alcohol, warfarin.
Serotonin syndrome occurs very rarely in patients treated with mirtazapine in combination with SSRIs or venlafaxine.
New ADR terms: bone marrow depression eosinophilia, increase in appetite, nightmares/ vivid dreams, mania, agitation, confusion, hallucinations, anxiety, insomnia, psychomotor restlessness, convulsions, paraesthesia, restless legs, syncope, somnolence, dizziness, headache, sedation, orthostatic hypotension, nausea, dry mouth, diarrhea, hypoaesthesia, mouth oedema, elevation in serum transaminase activities, exanthema, arthralgia, myalgia, fatigue, generalised or local oedema, weight gain. Some of these symptoms may be associated with the illness itself which are seen in depressed patients.
Hypersensitivity reactions, including anaphylactic reactions like oedema & angioedema, bronchospasm & anaphylactic shock have been reported very rarely. Rash is uncommonly reported.
During maintenance of anaesthesia, increasing the concentration of sevoflurane produces dose-dependent decreases in blood pressure which in turn may be related to depth of anaesthesia & this may be corrected by decreasing the inspired concentration of sevoflurane. Maintenance of hemodynamic stability is important to avoid myocardial ischaemia in patients with coronary artery disease.
New ADRs: Transient elevations in glucose & white blood cell count & occasional cases of transient changes in hepatic function tests, post-operative hepatitis (rare), hepatic failure (rare) & necrosis (rare); dystonic movement with spontaneous resolution in children, seizure-like activity of short duration, malignant hyperthermia, rash, urticaria, pruritus, bronchospasm, anaphylactic or anaphylactoid reactions.
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