Zita-Met (Generic Sitagliptin and Metformin Tablets)

Zita-Met Tablets (Generic Sitagliptin and Metformin Tablets)
© The Swiss Pharmacy

Zita-Met (Generic Sitagliptin Phosphate
Monohydrate and Metformin Hydrochloride
Tablets) helps to lower blood sugar levels in
patients with type 2 diabetes mellitus along with
diet and exercise.
Zita-Met tablets can be used alone, or in
combination with Ertugliflozin, Insulin, or
Sulfonylurea medicines such as Glimepiride,
Gliclazide and Glibenclamide.

Zita-Met Tablets are
manufactured by Glenmark
Pharmaceuticals Limited, India.

Metformin -Chemical Structure

Sitagliptin - Chemical Structure

The active ingredients contained in Zita-Met
tablets are Sitagliptin Phosphate
Monohydrate and Metformin Hydrochloride.
Each Zita-Met tablet contains 50 mg of
Sitagliptin and 500 mg of Metformin
Hydrochloride.

Uses of Zita-Met 550 mg Tablets:
Zita-Met is a combination of Sitagliptin Phosphate Monohydrate, a dipeptidyl
peptidase-4 (DPP-4) inhibitor, and Metformin Hydrochloride, a biguanide,
indicated as an adjunct to diet and exercise and possibly with other
medications to improve glycemic control in adults with type 2 diabetes
mellitus. It is used in patients with type 2 diabetes.
This product contains 2 medications. Sitagliptin Phosphate works by
increasing levels of natural substances called incretins. Incretins help to
control blood sugar by increasing insulin release, especially after a meal. They
also decrease the amount of sugar your liver makes.
Metformin Hydrochloride works by helping to restore your body's proper
response to the insulin you naturally produce. It also decreases the amount of
sugar that your liver makes and that your stomach/intestines absorb.

Recommended Adult Dosage
The dose of
Zita-Met (Generic Sitagliptin and Metformin Tablets) should
be given twice daily with meals, with gradual dose escalation,
to reduce the gastrointestinal (GI) side effects due to
Metformin.
The starting dose of Zita-Met must be individualized based
on the patient’s current regimen. The dosing could be adjusted
based on effectiveness and tolerability while not exceeding the
maximum recommended daily dose of 100 mg Sitagliptin
and 2000 mg Metformin.

Recommended Adult Dosage
Before starting treatment, assess renal function with
estimated glomerular filtration rate (eGFR).
Zita-Met should not be used in patients with eGFR below 30
mL/min/1.73 m2.
Zita-Met is not recommended in patients with eGFR between
30 and less than 45 mL/min/1.73 m2.
Zita-Met may need to be discontinued at time of, or prior to,
iodinated contrast imaging procedures.

Contraindications
➔
Zita-Met Tablets is contraindicated in patients with a known
hypersensitivity such as anaphylaxis or angioedema to Sitagliptin
Phosphate, Metformin Hydrochloride or any component of the tablet.
➔
Renal dysfunction, e.g., serum creatinine 1.5 mg/dL or more [males],
1.4 mg/dL or more [females] or abnormal creatinine clearance.
➔
Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or
without coma.
➔
Temporarily discontinue Zita-Met tablets in patients undergoing radiologic
studies involving intravascular administration of iodinated contrast
materials.

Storage Instructions
Zita-Met (Generic Sitagliptin Phosphate and
Metformin Hydrochloride Tablets) have to be
stored at controlled room temperature i.e. from
20°C to 25°C (68°F to 77°F) with excursions
permitted between 15° to 30°C (59° to 86°F).
Keep this as well as all other medicines away
from children and pets.

Warnings
Lactic acidosis can occur due to Metformin accumulation. The risk
increases with conditions such as sepsis, dehydration, excess alcohol
intake, hepatic insufficiency, renal impairment, and acute congestive
heart failure.
Symptoms include malaise, myalgias, respiratory distress,
increasing somnolence, and nonspecific abdominal distress. Laboratory
abnormalities include low pH, increased anion gap and elevated
blood lactate.
If acidosis is suspected, discontinue Zita-Met and hospitalize the patient
immediately.
Do not use Zita-Met (Generic Sitagliptin and Metformin Tablets) in
patients with hepatic disease.

Warnings
There have been postmarketing reports of acute renal failure,
sometimes requiring dialysis. Before initiating Zita-Met tablets and
at least annually thereafter, assess renal function and verify as normal.
There have been postmarketing reports of acute pancreatitis,
including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. If
pancreatitis is suspected, promptly discontinue Zita-Met.
Measure hematologic parameters annually.
Warn patients against excessive alcohol intake.
May need to discontinue Zita-Met and temporarily use insulin
during periods of stress and decreased intake of fluids and food as may
occur with fever, trauma, infection or surgery.

Warnings
Promptly evaluate patients previously controlled on Zita-Met who
develop laboratory abnormalities or clinical illness for evidence of
ketoacidosis or lactic acidosis.
There have been postmarketing reports of serious allergic and
hypersensitivity reactions in patients treated with Sitagliptin (one of
the components of Zita-Met), such as anaphylaxis, angioedema, and
exfoliative skin conditions including Stevens-Johnson
syndrome.
In such cases, promptly stop Zita-Met, assess for other potential causes,
institute appropriate monitoring and treatment, and initiate alternative
treatment for diabetes.

Warnings
When used with an insulin secretagogue (e.g., sulfonylurea) or
with insulin, a lower dose of the insulin secretagogue or
insulin may be required to reduce the risk of hypoglycemia.
There have been no clinical studies establishing
conclusive evidence of macrovascular risk reduction with
Zita-Met or any other anti-diabetic drug.

Possible Side Effects
Most common Zita-Met (Generic Sitagliptin
Phosphate and Metformin Hydrochloride Tablets)
side effects with an incidence rate of greater than or
equal to 5% and more commonly than in
patients treated with placebo were diarrhea,
upper respiratory tract infection, and headache.

The following are the serious side effects of this
medication: Lactic Acidosis, Pancreatitis, Heart Failure,
Acute Renal Failure, Vitamin B12 Deficiency,
Hypoglycemia with Concomitant Use with Insulin or
Insulin Secretagogues , Hypersensitivity Reactions,
Severe and Disabling Arthralgia and Bullous
Pemphigoid

Additional side effects have been identified during postapproval use of
Sitagliptin and Metformin Tablets (Zita-Met), Sitagliptin, or Metformin:
Hypersensitivity reactions including anaphylaxis, angioedema, rash,
urticaria, cutaneous vasculitis, and exfoliative skin conditions including
Stevens-Johnson syndrome; upper respiratory tract infection; hepatic
enzyme elevations; acute pancreatitis, including fatal and non-fatal
hemorrhagic and necrotizing pancreatitis; worsening renal function,
including acute renal failure (sometimes requiring dialysis); severe and
disabling arthralgia; bullous pemphigoid; constipation; vomiting; headache;
myalgia; pain in extremity; back pain; pruritus; mouth ulceration;
stomatitis; cholestatic, hepatocellular, and mixed hepatocellular liver
injury; rhabdomyolysis.

Zita-Met Tablets Overdosage
In the event of an overdose, it is reasonable to employ supportive
measures, e.g., remove unabsorbed material from the gastrointestinal
tract, employ clinical monitoring (including obtaining an
electrocardiogram), and institute supportive therapy as indicated by the
patient's clinical status.
Sitagliptin Phosphate is modestly dialyzable. In clinical studies,
approximately 13.5% of the dose was removed over a 3- to 4-hour
hemodialysis session. Prolonged hemodialysis may be considered if
clinically appropriate. It is not known if Sitagliptin is dialyzable by
peritoneal dialysis.

Zita-Met Tablets Overdosage
Overdose of Metformin Hydrochloride has occurred, including ingestion
of amounts greater than 50 grams. Hypoglycemia was reported in
approximately 10% of cases, but no causal association with Metformin
HCl has been established.
Lactic acidosis has been reported in approximately 32% of Metformin
overdose cases.
Metformin is dialyzable with a clearance of up to 170 mL/min under
good hemodynamic conditions. Therefore, hemodialysis may be useful
for removal of accumulated drug from patients in whom Metformin
Hydrochloride overdosage is suspected.

Zita-Met During Pregnancy
Zita-Met (Sitagliptin Phosphate and Metformin Hydrochloride Tablets)
has been classified by the US FDA as Pregnancy Category B.
There are no adequate and well-controlled studies in pregnant women
with Zita-Met tablets or its individual components. Therefore, the safety
of Zita-Met in pregnant women is not known.
Zita-Met should be used during pregnancy only if clearly needed.
Sitagliptin Reproduction studies have been performed in rats and
rabbits. Doses of Sitagliptin up to 125 mg/kg (approximately 12 times
the human exposure at the maximum recommended human dose) did
not impair fertility or harm the fetus. There are, however, no adequate
and well-controlled studies with Sitagliptin in pregnant women.

Zita-Met During Pregnancy
Metformin Hydrochloride was not teratogenic in rats and
rabbits at doses up to 600 mg/kg/day.
This represents an exposure of about 2 and 6 times the
maximum recommended human daily dose of 2,000 mg based
on body surface area comparisons for rats and rabbits,
respectively. Determination of fetal concentrations
demonstrated a partial placental barrier to Metformin.

Zita-Met Tablets are manufactured by
Glenmark Pharmaceuticals Limited, India.
For More details Click Here

Zita-Met (Generic Sitagliptin and Metformin Tablets)

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