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Synjardy
Overview
What is Synjardy?
SYNJARDY XR (empagliflozin and metformin hydrochloride extended-release)
tablets, for oral use, contain two antihyperglycemic drugs used in
the management of type 2 diabetes: empagliflozin and metformin hydrochloride.
Empagliflozin
The chemical name of empagliflozin is D-Glucitol,1,5-anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3-furanyl]oxy]phenyl]methyl]phenyl]-,
(1S).
Its molecular
formula is C•HClO and the molecular weight is 450.91. The structural
formula is:
Empagliflozin is a white to yellowish, non-hygroscopic
powder. It is very slightly soluble in water, sparingly soluble in
methanol, slightly soluble in ethanol and acetonitrile; soluble in
50% acetonitrile/water; and practically insoluble in toluene.
Metformin hydrochloride
N,N
Each film-coated tablet of SYNJARDY XR consists
of an extended-release metformin hydrochloride core tablet that is
coated with the immediate-release drug substance empagliflozin.
SYNJARDY XR tablets for oral
administration are available in four dosage strengths containing:
Each film-coated tablet
of SYNJARDY XR contains the following inactive ingredients: Tablet
Core: polyethylene oxide, hypromellose, and magnesium stearate. Film
Coatings and Printing Ink: hypromellose, titanium dioxide, polydextrose,
polyethylene glycol, talc, carnauba wax, purified water, ferrosoferric
oxide, propylene glycol, isopropyl alcohol, ferric oxide yellow (5
mg/1000 mg, 10 mg/1000 mg, 25 mg/1000 mg), ferric oxide red (10 mg/1000
mg), FD&C blue#2/indigo carmine aluminum lake (12.5 mg/1000 mg,
25 mg/1000 mg).
What does Synjardy look like?
What are the available doses of Synjardy?
p23051301513653360
SYNJARDY XR Tablets
3
What should I talk to my health care provider before I take Synjardy?
How should I use Synjardy?
SYNJARDY XR is a combination of empagliflozin
and metformin hydrochloride indicated as an adjunct to diet and exercise
to improve glycemic control in adults with type 2 diabetes mellitus
when treatment with both empagliflozin and metformin hydrochloride
is appropriate.
Empagliflozin
is indicated to reduce the risk of cardiovascular death in adults
with type 2 diabetes mellitus and established cardiovascular disease . However, the effectiveness of SYNJARDY XR on reducing the risk
of cardiovascular death in adults with type 2 diabetes mellitus and
cardiovascular disease has not been established.
Limitations of Use
[see
Warnings and Precautions ()]
Individualize the starting dose of SYNJARDY XR based on
the patient’s current regimen ()
The maximum recommended total daily dose is 25 mg empagliflozin
and 2000 mg metformin hydrochloride ()
Take once daily with a meal in the morning, with gradual
dose escalation to reduce the gastrointestinal side effects due to
metformin ()
Swallow whole; do not split, crush, dissolve, or chew ()
Assess renal function before initiating. SYNJARDY XR is
contraindicated in patients with an eGFR below 45 mL/min/1.73 m (, )
SYNJARDY XR may need to be discontinued at time of, or prior
to, iodinated contrast imaging procedures ()
What interacts with Synjardy?
Sorry No Records found
What are the warnings of Synjardy?
Sorry No Records found
What are the precautions of Synjardy?
Sorry No Records found
What are the side effects of Synjardy?
Sorry No records found
What should I look out for while using Synjardy?
SYNJARDY XR is contraindicated
in patients with:
Postmarketing cases of metformin-associated
lactic acidosis have resulted in death, hypothermia, hypotension,
and resistant bradyarrhythmias. The onset of metformin-associated
lactic acidosis is often subtle, accompanied only by nonspecific symptoms
such as malaise, myalgias, respiratory distress, somnolence, and abdominal
pain. Metformin-associated lactic acidosis was characterized by elevated
blood lactate levels (>5 mmol/Liter), anion gap acidosis (without
evidence of ketonuria or ketonemia), an increased lactate/pyruvate
ratio; and metformin plasma levels generally >5 mcg/mL .
Risk
factors for metformin-associated lactic acidosis include renal impairment,
concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors
such as topiramate), age 65 years old or greater, having a radiological
study with contrast, surgery and other procedures, hypoxic states
(e.g., acute congestive heart failure), excessive alcohol intake,
and hepatic impairment.
Steps to reduce the risk of and manage
metformin-associated lactic acidosis in these high risk groups are
provided in the full prescribing information
If metformin-associated lactic acidosis is suspected, immediately
discontinue SYNJARDY XR and institute general supportive measures
in a hospital setting. Prompt hemodialysis is recommended
What might happen if I take too much Synjardy?
In the event of an overdose with
SYNJARDY XR, contact the Poison Control Center. Employ the usual
supportive measures (e.g., remove unabsorbed material from the gastrointestinal
tract, employ clinical monitoring, and institute supportive treatment)
as dictated by the patient’s clinical status. Removal of empagliflozin
by hemodialysis has not been studied. However, metformin is dialyzable
with a clearance of up to 170 mL/min under good hemodynamic conditions.
Therefore, hemodialysis may be useful partly for removal of accumulated
metformin from patients in whom SYNJARDY XR overdosage is suspected.
Metformin hydrochloride
[see and Warnings and Precautions ()].
How should I store and handle Synjardy?
StorageStore Pantoprazole Sodium Delayed-Release Tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [ ]. StorageStore Pantoprazole Sodium Delayed-Release Tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [ ]. SYNJARDY XR (empagliflozin and metformin hydrochloride extended-release) tablets are available in the following strengths and packages:StorageStore at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F)SYNJARDY XR (empagliflozin and metformin hydrochloride extended-release) tablets are available in the following strengths and packages:StorageStore at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F)SYNJARDY XR (empagliflozin and metformin hydrochloride extended-release) tablets are available in the following strengths and packages:StorageStore at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F)
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
SYNJARDY XR
Empagliflozin
Metformin hydrochloride
[see Warnings and Precautions ()]
Non-Clinical Toxicology
SYNJARDY XR is contraindicated in patients with:Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL .
Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment.
Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the full prescribing information
If metformin-associated lactic acidosis is suspected, immediately discontinue SYNJARDY XR and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended
Caution should be exercised when propranolol hydrochloride tablets are administered with drugs that have an effect on CYP2D6, 1A2, or 2C19 metabolic pathways. Coadministration of such drugs with propranolol may lead to clinically relevant drug interactions and changes on its efficacy and/or toxicity (see ).
Cardiovascular Drugs
Antiarrhythmics
Propafenone has negative inotropic and beta-blocking properties that can be additive to those of propranolol.
Quinidine increases the concentration of propranolol and produces greater degrees of clinical beta-blockade and may cause postural hypotension.
Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with β-blockers such as propranolol.
The clearance of lidocaine is reduced with administration of propranolol. Lidocaine toxicity has been reported following coadministration with propranolol.
Caution should be exercised when administering propranolol hydrochloride tablets with drugs that slow A-V nodal conduction, e.g. digitalis, lidocaine and calcium channel blockers.
Digitalis Glycosides
Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
Calcium Channel Blockers
Caution should be exercised when patients receiving a beta-blocker are administered a calcium-channel-blocking drug with negative inotropic and/or chronotropic effects. Both agents may depress myocardial contractility or atrioventricular conduction.
There have been reports of significant bradycardia, heart failure, and cardiovascular collapse with concurrent use of verapamil and beta-blockers.
Coadministration of propranolol and diltiazem in patients with cardiac disease has been associated with bradycardia, hypotension, high degree heart block, and heart failure.
ACE Inhibitors
When combined with beta-blockers, ACE inhibitors can cause hypotension, particularly in the setting of acute myocardial infarction.
The antihypertensive effects of clonidine may be antagonized by beta-blockers. Propranolol hydrochloride tablets should be administered cautiously to patients withdrawing from clonidine.
Alpha Blockers
Prazosin has been associated with prolongation of first dose hypotension in the presence of beta-blockers.
Postural hypotension has been reported in patients taking both beta-blockers and terazosin or doxazosin.
Reserpine
Patients receiving catecholamine-depleting drugs, such as reserpine, should be closely observed for excessive reduction of resting sympathetic nervous activity, which may result in hypotension, marked bradycardia, vertigo, syncopal attacks, or orthostatic hypotension.
Inotropic Agents
Patients on long term therapy with propranolol may experience uncontrolled hypertension if administered epinephrine as a consequence of unopposed alpha-receptor stimulation. Epinephrine is therefore not indicated in the treatment of propranolol overdose (see ).
Isoproterenol and Dobutamine
Propranolol is a competitive inhibitor of beta-receptor agonists, and its effects can be reversed by administration of such agents, e.g., dobutamine or isoproterenol. Also, propranolol may reduce sensitivity to dobutamine stress echocardiography in patients undergoing evaluation for myocardial ischemia.
There have been postmarketing cases of metformin-associated lactic acidosis, including fatal cases. These cases had a subtle onset and were accompanied by nonspecific symptoms such as malaise, myalgias, abdominal pain, respiratory distress, or increased somnolence; however, hypothermia, hypotension, and resistant bradyarrhythmias have occurred with severe acidosis. Metformin-associated lactic acidosis was characterized by elevated blood lactate concentrations (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), and an increased lactate:pyruvate ratio; metformin plasma levels generally >5 mcg/mL. Metformin decreases liver uptake of lactate increasing lactate blood levels which may increase the risk of lactic acidosis, especially in patients at risk.
If metformin-associated lactic acidosis is suspected, general supportive measures should be instituted promptly in a hospital setting, along with immediate discontinuation of SYNJARDY XR. In SYNJARDY XR-treated patients with a diagnosis or strong suspicion of lactic acidosis, prompt hemodialysis is recommended to correct the acidosis and remove accumulated metformin (metformin is dialyzable, with a clearance of up to 170 mL/minute under good hemodynamic conditions). Hemodialysis has often resulted in reversal of symptoms and recovery.
Educate patients and their families about the symptoms of lactic acidosis and if these symptoms occur instruct them to discontinue SYNJARDY XR and report these symptoms to their healthcare provider.
For each of the known and possible risk factors for metformin-associated lactic acidosis, recommendations to reduce the risk of and manage metformin-associated lactic acidosis are provided below:
Drug Interactions:
[see Drug Interactions ()]
Age 65 or Greater:
[see Use in Specific Populations ()]
Radiological Studies with Contrast:
Surgery and Other Procedures:
Hypoxic States:
Excessive Alcohol Intake:
Hepatic Impairment:
The following important adverse reactions are described below and elsewhere in the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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