The Renal Drug Handbook, 3rd Edition

Product Information

If urinary Na+/K+ ratio is greater than 1, give 100mg daily. If the ratio is less than 1, give 200mg to 400mg daily.

Summary of Product Characteristics: Spironolactone Film-coated Tablets 12.5mg. ADVANZ Pharma. Revised October 2020. Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk. Dose in renal impairment: The level of renal function below which the dose of a drug must be reduced depends largely on the extent of renal metabolism and elimination, and on the drug’s toxicity. Most drugs are relatively well tolerated, have a broad therapeutic index or are metabolised and excreted hepatically, so precise dose modification is unnecessary. In such cases, the user is instructed to ‘dose as in normal renal function’. The following details the structure of the monographs found within The Renal Drug Database. Where appropriate, supporting information is provided.Patients who tolerate 25mg once daily may have their dose increased to 50mg once daily as clinically indicated. Patients who do not tolerate 25mg once daily may have their dose reduced to 25mg every other day. Advise patient on contraception required. If appropriate, advise patient to consider sperm cyropreservation. In fluorometric assays, spironolactone may interfere with the estimation of compounds with similar fluorescence characteristics. Overdosage

For many drugs, some or even all of the altered pharmacokinetic parameters and modified interrelationships are unknown. In such circumstances, the informed professional judgement of clinicians and pharmacists must be used to predict drug disposition. This must be based on knowledge of the drug, its class, chemistry and pharmacokinetics in patients with normal renal function. In addition to our own resources, we recommend the following resources for information about specific medicines in renal impairment. Diuretics are not recommended for use during pregnancy because of theoretical concerns that they may further reduce the circulatory blood volume in women with pre-eclampsia. If therapy is essential, the development of oligohydramnios should be ruled out in long term treatment. Hypoglycaemia in the newborn should also be determined. Schaefer (2007) concludes that therapy with a diuretic is not an indication for interrupting the pregnancy.Blood Results in Clinical Practice: A Practical Guide to Interpreting Blood Test Results - 2nd ed. (2019) This is a much-needed reference with good and precise explanations of relevant drugs. One of the noteworthy aspects is that the authors have tried their best to translate the important information into a concise but effective format. The authors must be applauded for maintaining the uniform presentation structure for each drug monograph. Overall, this is an excellent handbook for anybody who wants to learn about drugs at a glance or wishes a quality reference for prescribing for those with renal impairment. The manufacturer recommends a washout period of around 1 week after a single-dose or discontinuation of a course of treatment before becoming pregnant. Pregnancy and Lactation Pregnancy

CRC Press publishes medical books across a wide range of therapy areas including Toxicology, Pharmaceutical Science, Infectious Disease, Oncology, Nephrology, Gastroenterology and Hepatology. CRC Press authors and editors are among the leaders in medical science, and many of our publications document the notable contributions they have made to their own specialist fields. You can find details about all our books by visiting https://www.crcpress.com/medicine Fluconazole appears to be teratogenic in the first trimester of pregnancy with continual doses of 400mg per day or greater. In one large study, exposure to oral cumulative doses 450mg or less of fluconazole in first trimester was associated with a small increased risk of musculoskeletal malformations. Lower doses of fluconazole suggest low to minimal risk of adverse reactions. Data shows no increase in the overall risk of malformations in the fetus when pregnant women being treated with cumulative dose of 150mg or less with fluconazole. Briggs (2015) recommends to inform patient of the potential risk to the fetus if continual high doses of fluconazole are essential during the first trimester of pregnancy. Spironolactone has been found to be carcinogenic in rodents when administered at high doses over a long period of time. Long term use in young patients requires careful consideration. Small studies have shown that doses of 25mg spironolactone three times per week can be used safely in haemodialysis patients although it is unknown whether or not this dose would have any therapeutic benefit. Potassium levels should be monitored closely. Contraindications Altered pharmacokinetics of some drugs, i.e. changes in absorption, tissue distribution, extent of plasma protein binding, metabolism and excretion. In renal impairment these parameters are often variable and interrelated in a complex manner. This may be further complicated if the patient is undergoing renal replacement therapy.Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press. Accessed on 03 June 2015. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia. Summary of Product Characteristics: Terbinafine 250 mg tablets. Aurobindo pharma. Revised November 2017 Dose in renal replacement therapy: Details are given for dosing in continuous ambulatory peritoneal dialysis ( CAPD), intermittent haemodialysis ( HD), intermittent haemodiafiltration ( HDF), continuous venovenous haemodialysis/haemodiafiltration (CVV HD/HDF), and continuous arteriovenous haemodialysis/haemodiafiltration (CAV HD/HDF), where known. Drugs are categorised into dialysable/not dialysable/dialysability unknown, to aid the practitioner in making an informed decision for dosing within a particular form of renal replacement therapy. Only a few specific guidelines are given for dosing in continuous arteriovenous/venovenous haemofiltration (CAV/VVH). In general, dosing schedules are the same as those quoted for CAV/VVHD, although it should be borne in mind that CAV/VVH may have a lower drug clearance capacity. Thus the clinician or pharmacist should use informed professional judgement, based on knowledge of the drug and its pharmacokinetics, when deciding whether to further modify dosing regimens. The use of drugs in patients with impaired renal function can give rise to problems for several reasons:

For renally excreted drugs with a narrow therapeutic index, the total daily maintenance dose may be reduced either by decreasing the dose or by increasing the dosing interval, or sometimes by a combination of both. Dosing guidelines for varying degrees of renal impairment are stated accordingly. Launched in 2014, The Renal Drug Database comprises all monograph information from the highly successful The Renal Drug Handbook, the universally-trusted resource for pharmacists seeking definitive prescribing information when treating patients with renal impairment. Antiandrogenic effects have been seen in humans and feminization in male rat foetuses has been observed with spironolactone. In one study, rat offspring of both sexes exposed in utero in late gestation exhibited permanent dose related changes in their reproductive tracts. In animal experiments carcinogenic effects have been seen, although as yet, there are no indications of any clinical relevance of this finding to humans. No reports associating spironolactone to congenital defects (cardiovascular defects, spina bifida, polydactyly, limb reduction defects and hypospadias) in human pregnancies have been found (Briggs, 2011). Quinine should be used only for the treatment of chloroquine-resistant malaria as the potential risk to the foetus due to treatment is much less than risks due to severe disease. Pregnant women treated with quinine are at risk of hypoglycaemia caused or exacerbated by quinine-induced hyperinsulinaemia.Advise patients to report any signs or symptoms of unexplained persistent nausea, decreased appetite, fatigue, vomiting, right upper abdominal pain, or jaundice, dark urine or pale faeces. Side Effects Avoid using oral potassium supplements in patients with serum potassium greater than 3.5 mEq/l. The recommended monitoring for potassium and creatinine is 1 week after initiation or increase in dose of spironolactone, monthly for the first 3 months, then quarterly for a year, and then every 6 months. Pregnancy and Lactation Pregnancy Administration: Information is given on reconstitution, route and rate of administration, and other relevant factors. Much of the information relates to local practice, including information on the minimum volume that drugs can be added to. Only the most commonly used and compatible reconstitution and dilution solutions are stated. The product literature should always be consulted for the most up to date information. Summary of Product Characteristics: Azocan 50mg capsules. FDC International Ltd. Revised June 2016.