There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations].

In animal studies, adverse renal changes were observed in rats when empagliflozin was administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy. Doses approximately times the maximum clinical dose caused renal pelvic and tubule dilatations that were reversible. The estimated background risk of miscarriage for the indicated population is unknown. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity.

These findings were not observed after a 13 week drug-free recovery period. These outcomes occurred with drug exposure during periods of renal development in rats that correspond to the late second and third trimester of human renal development.

In embryo-fetal development studies in rats and rabbits, empagliflozin was administered for intervals coinciding with the first trimester period of organogenesis in humans. Empagliflozin crosses the placenta and reaches fetal tissues in rats. Empagliflozin is present in the milk of lactating rats [see Data]. Since human kidney maturation occurs in utero and during the first 2 years of life when lactational exposure may occur, there may be risk to the developing human kidney.

Because of the potential for serious adverse reactions in a breastfed infant, including the potential for empagliflozin to affect postnatal renal development, advise women that use of JARDIANCE is not recommended while breastfeeding.

Data Empagliflozin was present at a low level in rat fetal tissues after a single oral dose to the dams at gestation day In rat milk, the mean milk to plasma ratio ranged from 0. The mean maximal milk to plasma ratio of 5 occurred at 8 hours post-dose, suggesting accumulation of empagliflozin in the milk. Plant Physiol ; 2: Adjunctive treatment with oral AKL1, a botanical nutraceutical, in chronic obstructive pulmonary disease.

An in vitro evaluation of human cytochrome P 3A4 inhibition by selected commercial herbal extracts and tinctures. Effect of treatment with Ginkgo biloba extract EGb oral on unilateral idiopathic sudden hearing loss in a prospective randomized double-blind study of outpatients. Eur Arch Otorhinolaryngol ; Adverse interactions between herbal and dietary substances and prescription medications: Altern Ther Health Med ; Properties and interaction of heterologously expressed glutamate decarboxylase isoenzymes GAD 65kDa and GAD 67kDa from human brain with ginkgotoxin and its 5'-phosphate.

J Med Chem ; Inhibition of type 4 phosphodiesterase by rolipram and Ginkgo biloba extract EGb decreases agonist-induced rises in internal calcium in human endothelial cells. Arterioscler Thromb Vasc Biol ; Effects of Gingko biloba supplementation in Alzheimer's disease patients receiving cholinesterase inhibitors: Ginkgo biloba EGb in the treatment of equilibrium disorders. Influence of the Ginkgo extract EGb on rat liver cytochrome P and steroid metabolism and excretion in rats and man. J Pharm Pharmacol ; Cohen AJ, Bartlik B.

Ginkgo biloba for antidepressant-induced sexual dysfunction. Assessment of a pharmacokinetic and pharmacodynamic interaction between simvastatin and Ginkgo biloba extracts in healthy subjects. J Am Geriatr Soc ; Davydov L, Stirling AL. Stevens-Johnson syndrome with Ginkgo biloba. J Herb Pharmacother ;1: Ginkgo biloba for prevention of dementia. Bilateral haematoma after rhytidoplasty and blepharoplasty following chronic use of Ginkgo biloba.

Br J Plast Surg ; Preventing the acute skin side effects in patients treated with radiotherapy for breast cancer: A randomized controlled pilot trial: Explore NY ;9 2: Arch Phys Med Rehabil ; A randomized placebo-controlled trial of ginkgo biloba for the prevention of cognitive decline.

Neurology ;70 19 Pt 2: Drew S, Davies E. Effectiveness of Ginkgo biloba in treating tinnitus: Safety and efficacy of ginkgo Ginkgo biloba during pregnancy and lactation. Can J Clin Pharmacol ; Fluoxetine-induced genital anesthesia relieved by Ginkgo biloba extract. J Clin Psychiatry ; Clastogenic factors in the plasma of Chernobyl accident recovery workers: Effect of coenzyme Q10 and Ginkgo biloba on warfarin dosage in stable, long-term warfarin treated outpatients. A randomised, double blind, placebo-crossover trial.

Ginkgo biloba extract for age-related macular degeneration. Ginkgo biloba extract EGb influences monoaminergic neurotransmission via inhibition of NE uptake, but not MAO activity after chronic treatment. Fies P, Dienel A. Wien Med Wochenschr ; Retrobulbar haemorrhage associated with chronic Ginkgo biloba ingestion.

Clinical issues in current drug therapy for dementia. Alzheimer Dis Assoc Disord ; Coma in a patient with Alzheimer's disease taking low dose trazodone and Ginkgo biloba. J Neurol Neurosurg Psychiatry ; Gardiner P, Wornham W. Recent review of complementary and alternative medicine used by adolescents. Curr Opin Pediatr ; Effect of Ginkgo biloba EGb on treadmill walking time among adults with peripheral artery disease: J Cardiopulm Rehabil Prev ; Inhibition of human P enzymes by multiple constituents of the Ginkgo biloba extract.

Biochem Biophys Res Comm ; Randomised, double blind, placebo controlled comparison of ginkgo biloba and acetazolamide for prevention of acute mountain sickness among Himalayan trekkers: Ginkgo biloba for SSRI-induced sexual dysfunction. Ginkgo biloba precipitating epileptic seizures. Seizure associated with Ginkgo biloba? Ann Intern Med ; Effects of Ginkgo biloba extracts on pharmacokinetics and efficacy of atorvastatin based on plasma indices.

Effect of Ginkgo biloba on visual field and contrast sensitivity in Chinese patients with normal tension glaucoma: Invest Ophthalmol Vis Sci ;55 1: Jardiance 25 mg film-coated tablets Each tablet contains 25 mg empagliflozin.

For the full list of excipients, see section 6. Pharmaceutical form Film-coated tablet tablet. The maximum daily dose is 25 mg see below and section 4. When empagliflozin is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia see sections 4.

Special populations Renal impairment Due to the mechanism of action, the glycaemic efficacy of empagliflozin is dependent on renal function. Empagliflozin should not be used in patients with end stage renal disease ESRD or in patients on dialysis as it is not expected to be effective in these patients see sections 4. Hepatic impairment No dose adjustment is required for patients with hepatic impairment.

Empagliflozin exposure is increased in patients with severe hepatic impairment. Therapeutic experience in patients with severe hepatic impairment is limited and therefore not recommended for use in this population see section 5. Elderly No dose adjustment is recommended based on age.

In patients 75 years and older, an increased risk for volume depletion should be taken into account see sections 4. In patients aged 85 years and older, initiation of empagliflozin therapy is not recommended due to the limited therapeutic experience see section 4. Paediatric population The safety and efficacy of empagliflozin in children and adolescents has not yet been established. FARXIGA causes intravascular volume contraction and renal impairment, with reports of acute kidney injury requiring hospitalization and dialysis.

Consider temporarily discontinuing in settings of reduced oral intake or fluid losses. If acute kidney injury occurs, discontinue and promptly treat.

Elderly patients and patients with impaired renal function may be more susceptible to these changes. Evaluate for signs and symptoms of UTIs and treat promptly Hypoglycemia: At mg, one subject experienced oedema of the feet and hands, and increases in creatine phosphokinase CPK , aspartate aminotransferase AST , C-reactive protein CRP and myoglobin levels.

Three other subjects experienced oedema of the feet, with paraesthesia in two cases. All symptoms and laboratory abnormalities resolved without treatment after discontinuation of the study medicinal product.

Management In the event of an overdose, supportive management is recommended. Vildagliptin cannot be removed by haemodialysis. However, the major hydrolysis metabolite LAY can be removed by haemodialysis. Pharmacological properties Pharmacotherapeutic group: Mechanism of action The administration of vildagliptin results in a rapid and complete inhibition of DPP-4 activity, resulting in increased fasting and postprandial endogenous levels of the incretin hormones GLP-1 glucagon-like peptide 1 and GIP glucose-dependent insulinotropic polypeptide.

A slight delay in parturition was observed in the majority of treated rats. Group mean body weight of neonatal rats from liraglutide-treated dams was lower than neonatal rats from control group dams. Group mean body weight from birth to postpartum day 14 trended lower in F2 generation rats descended from liraglutide-treated rats compared to F2 generation rats descended from controls, but differences did not reach statistical significance for any group.

Lactation Risk Summary There are no data on the presence of Victoza in human milk, the effects on the breastfed infant, or the effects on milk production. Liraglutide was present in milk of lactating rats [see Data].

Pediatric Use Safety and effectiveness of Victoza have not been established in pediatric patients. Victoza is not recommended for use in pediatric patients. Geriatric Use In the Victoza treatment arms of the glycemic control trials, a total of No overall differences in safety or efficacy were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

No overall differences in safety or efficacy were observed between these patients and younger patients. Renal Impairment No dose adjustment of Victoza is recommended for patients with renal impairment [see Clinical Pharmacology No overall differences in safety or efficacy were seen in these patients compared to patients with normal renal function.

There is limited experience with Victoza in patients with end stage renal disease. There have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis [see Warnings and Precautions 5. Use caution in patients who experience dehydration.

Hepatic Impairment There is limited experience in patients with mild, moderate or severe hepatic impairment. Therefore, Victoza should be used with caution in this patient population. No dose adjustment of Victoza is recommended for patients with hepatic impairment [ see Clinical Pharmacology Gastroparesis Victoza slows gastric emptying.

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